Nuvon Vitals Charting System
by Nuvon, Inc.
510(k) K130234
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK130234 | Date13 Mar 2013 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MWI
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2300
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Nuvon Vitals Charting System is a Medical Information Display Device (product code MWI) designed for real-time monitoring and display of patient vital signs. It integrates with the Nuvon VEGA System to provide surveillance of monitored patients at the point of care and remotely via wide area networking. The system facilitates continuous tracking of physiological parameters, enabling clinical staff to assess patient status dynamically. Its classification as a Class 2 Cardiovascular device reflects its role in supporting cardiovascular patient monitoring environments.
This system is supplied as a standalone accessory for use with compatible monitoring platforms, requiring no additional sterility measures beyond standard IT and network hygiene. It is intended for reusable deployment in clinical settings, including hospitals and remote care locations, where network connectivity is available. The device operates within standard MRI safety guidelines for non-MRI environments and does not require specialized storage conditions. Authorized for use in the United States under FDA 510(k) clearance (K130234), it adheres to regulatory pathways established for cardiovascular information display devices.
Other devices from Nuvon, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Nuvon Vitals Charting System used for?
The Nuvon Vitals Charting System is a Medical Information Display Device designed for real-time monitoring and continuous tracking of patient physiological parameters. It integrates with the Nuvon VEGA System to display vital signs at the point of care and remotely via network connectivity, enabling clinical staff to assess cardiovascular patient status dynamically in environments like hospitals or remote care locations.
How is the Nuvon Vitals Charting System supplied and prepared for use?
The system is supplied as a standalone accessory for compatible monitoring platforms. Unlike some medical devices, it does not require additional sterility measures beyond standard IT and network hygiene. It is intended for reusable deployment in clinical settings, so no special sterilization procedures are needed—only routine cleaning and maintenance as per facility protocols.
Is the Nuvon Vitals Charting System single-use or reusable?
The Nuvon Vitals Charting System is designed for reusable deployment in clinical environments. It is not intended for single-use, and its durable construction aligns with the operational needs of hospitals and remote care settings where network connectivity is available. Reusability reduces waste and aligns with standard clinical workflows for monitoring devices.
Does the Nuvon Vitals Charting System require specialized storage conditions?
No, the system does not require specialized storage conditions. It operates within standard MRI safety guidelines for non-MRI environments, meaning it can be stored in typical clinical areas without additional precautions. Proper handling and network connectivity are the primary considerations for optimal performance.
What regulatory pathway does the Nuvon Vitals Charting System follow in the U.S.?
The Nuvon Vitals Charting System is authorized for use in the United States under FDA 510(k) clearance (K130234). It was classified as a Class 2 Cardiovascular device and follows the traditional 510(k) review pathway, with a decision of substantial equivalence to predicate devices. This pathway ensures compliance with regulatory standards for cardiovascular information display devices.